Results at 12 months from the FORWARD PAD investigational device exemption (IDE) and feasibility studies demonstrate low rates of major amputation and cardiovascular death in patients treated with the Javelin peripheral intravascular lithotripsy (IVL) catheter (J&J MedTech/Shockwave Medical). Andrew Holden (Auckland City Hospital, Auckland, New Zealand) shared the late-breaking findings at the 2025 Vascular Interventional Advances (VIVA) conference (2–5 November, Las Vegas, USA).
Holden noted that severe calcification, chronic total occlusions (CTOs), and medial calcification are obstacles for endovascular treatment of peripheral arterial disease (PAD) and contribute to high mortality and amputation rates. He detailed that, in complex patients, current calcium modification technologies can be limited by an inability to deliver across severely stenosed lesions and associated risks of vessel damage and distal embolisation.
The novel Javelin IVL catheter, Holden shared, uses acoustic pressure waves to safely modify calcification in extremely narrow crossing channels where other devices may be limited.
In the FORWARD PAD IDE and feasibility studies, 110 patients with 124 core lab-assessed lesions were enrolled. Twelve-month endpoints included major adverse events (MAEs), cardiovascular death, clinically driven target lesion revascularisation (CD-TLR), unplanned target limb major amputation, and patency.
Baseline lesion characteristics included 83.9% with severe calcification, diameter stenosis of 83±17.4%, and 41.7% CTOs. At final angiography, patients had an acute gain of 2.8±1.2mm, residual stenosis of 23.1±8.6%, and there was only one type D dissection.
The 12-month overall rate of MAE was 18.6% (19/102), with 3.9% (4/102) of patients experiencing cardiovascular death, 1% (1/102) undergoing major amputation, and 14.7% (15/102) having CD-TLR, Holden reported. Primary, primary-assisted, and secondary patency in above-the-ankle (ATK) lesions were 72.7%, 74.5%, and 76.4%, respectively. Primary, primary-assisted, and secondary patency in the below-the-knee (BTK) lesions were 61.5%, 78.4%, and 88.6%, respectively.
Holden concluded that, in heavily calcified and severely stenosed or completely occluded lesions, treatment with the Javelin IVL system resulted in stenosis reduction and acute gains without perforations or embolisation consistent with the prior balloon-based IVL studies. He added that the one-year patency, amputation, and revascularisation rates were comparable to prior clinical trials of heavily calcified lesions.
“Continued real-world assessments are ongoing to determine how the Javelin IVL catheter fits in the armamentarium of calcium-modifying technologies,” Holden informed the VIVA audience.
